Senior Quality Compliance Manager

🕒 Outubro 20

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $132.037 - $178.638 / ano

⏰ Tempo Integral

🟠 Sênior

🚔 Conformidade

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Amgen

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1980

🏥 Saúde

🧬 Biotecnologia

💊 Farmacêutico

💰 $28.500.000.000 Post-IPO Debt em 2022-12

Healthcare • Biotechnology • Pharmaceuticals

A Amgen está comprometida a liberar o potencial da biologia para pacientes que sofrem de doenças graves, descobrindo, desenvolvendo, fabricando e fornecendo terapias humanas inovadoras. Esta abordagem começa utilizando ferramentas como genética humana avançada para desvendar as complexidades das doenças e entender os fundamentos da biologia humana.

Descrição

• Lead the day-to-day operation of the Quality Intelligence Center (QuIC) and manage a professional team responsible for portfolio-level quality monitoring • Own and continuously improve the QuIC operating model, including review cadence, signal triage, documentation expectations, escalation pathways, action tracking, and governance routines • Establish review cadences and business standards for evaluating dashboard outputs, quality metrics, trends, anomalies, threshold breaches, and other QuIC-generated signals • Lead review and prioritization of quality signals to identify issues requiring assessment or follow-up • Translate deviations, CAPAs, audit and inspection insights, operational metrics, and related evidence into governance-ready summaries, recommendations, and escalations • Document, escalate, and route significant findings to accountable process owners and cross-functional stakeholders • Define and propose QuIC business rules, operating standards, documentation expectations, escalation pathways, and workflow requirements • Partner with R&D Quality, Global Development Operations, and other stakeholders to ensure QuIC insights are understood and acted upon • Lead process improvements and provide business leadership for QuIC enhancements, including signal definitions, thresholds, business rules, data-quality expectations, training, and adoption activities • Monitor the effectiveness, timeliness, quality, and capacity of oversight activities and implement practical improvements • Ensure activities comply with applicable GxP, quality-system, data-governance, and internal procedural requirements

🎯 Requisitos

• Doctorate degree and 2 years of Quality experience OR Master’s degree and 4 years of Quality experience OR Bachelor’s degree and 6 years of Quality experience OR Associate’s degree and 10 years of Quality experience OR High school diploma / GED and 12 years of Quality experience • Bachelor’s degree in scientific, clinical, quality, data, or related discipline, with substantial relevant experience in R&D Quality, clinical development, clinical operations, quality systems, risk management, or centralized monitoring • Experience leading and developing professional employees or leading complex cross-functional teams • Experience interpreting quality, operational, or risk data and converting findings into recommendations, escalations, and follow-up actions • Working knowledge of GCP, quality-risk management, issue management, CAPA and deviation processes, audit and inspection readiness, and quality governance • Experience as an R&D Quality process owner or in quality oversight across deviations, CAPAs, audits, inspections, management review, or risk-management processes • Experience with QMS platforms, dashboards, data visualization, data quality, business analysis, user acceptance testing, or digital-product implementation • Experience with risk-based quality management, centralized monitoring, KRIs, QTLs, CSM, or signal-based quality oversight • Experience with AI-enabled analytics or digital quality products, including critically evaluating system-generated insights and applying human judgment • Experience leading operational change in a global matrix environment • Sponsorship for this role is not guaranteed

🏖️ Benefícios

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions • Group medical, dental and vision coverage • Life and disability insurance • Flexible spending accounts • Discretionary annual bonus program • Stock-based long-term incentives • Award-winning time-off plans • Flexible work models where possible • Career development opportunities • Work/life balance support

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